This year’s EuroPCR conference was abuzz with lots of new innovations and market dynamics impacting the cardiovascular space. Our experts narrowed down 4 hot topics that will impact cardiovascular device companies the most.
Taking Coronary Imaging from the Fringe to the Routine
A major focus of the coronary imaging and physiology trials on display at EuroPCR 2019 was on post-percutaneous coronary intervention (PCI) analysis. Results of the FFR-SEARCH and HAWKEYE trials were particularly surprising; using flow fractional reserve (FFR) and quantitative flow ration (QFR), respectively, the studies demonstrated the successful identification of 30-40% of patients who showed below-threshold physiological flow immediately after intervention, which was higher than expected. Both studies pointed to various potential mechanisms that can be corrected following identification, including untreated lesions and stent underexpansion or malapposition. Pre-procedural technologies such as fractional flow reserve-computed tomography (FFR-CT) were also supported by further positive data, both of which continue to show comparable diagnostic accuracy and specificity compared to traditional FFR.
“Despite the best efforts of manufacturers and cardiovascular societies, technologies such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), and various permutations and uses of FFR concepts have seen only limited penetration into cath labs in most countries. However, the various trials on display at EuroPCR add to the increasing volume of positive clinical data that further drives recognition of these technologies as being essential to both pre-procedural planning and post-procedural validation. While clinical outcome data is still the missing component that is rightfully limiting large-scale adoption, interventionalists worldwide should be becoming increasingly aware that optimization of interventional procedures using these technologies will likely reduce long-term adverse clinical events. As more of this data emerges with continued technological advances, increasing physician expertise, and overall recognition of the potential to save operating costs, I fully anticipate the global uptake of these devices to reach levels that we’ve seen in Japan for some time.”
—Michael Tian, Principal Analyst, Cardiovascular Insights
Bioresorbable Scaffolds: New Data, New Hope?
After Abbott’s Absorb GT1 was pulled from the global markets in late 2017, the initial promise of bioresorbable stents appeared to lose some of its luster. However, mid-term data for some of the CE marked scaffolds presented in EuroPCR reported zero to minimal scaffold thrombosis. Meril Life Sciences’ MeRes-1 trial with 107 patients and MeRes-1 Extend study with 62 patients, which were both conducted to assess its MeRes100 scaffold, demonstrated major adverse cardiovascular event (MACE) rates of 1.87% and 1.61%, at 3 and 2 years, respectively. In addition, BIOTRONIK’s BIOSOLVE-IV trial–conducted to evaluate the Magmaris scaffold–not only confirmed low scaffold thrombosis and target lesion failure (TLF) rates at 12 months from previous trials, but also showed excellent device and procedure success rates of 97.1% and 98.8%, respectively.
At this year’s EuroPCR, data was also presented from country-specific bioresorable scaffold studies—such as 3-year results from the ABSORB UK real world registry—which showed favorable outcomes highlighting the importance of dual antiplatelet therapy (DAPT) and previous device experience.
“Mixed outcomes from the above results indicate that there is still substantial work to be done in the development of a perfect bioresorable scaffold before these can be considered as an alternative to existing drug-eluting stents (DES). The concept of “a fully resorbable device” remains attractive to the interventional community, and existing manufacturers stand to capitalize on the vacuum left by Abbott Laboratories in this segment. According to the key opinion leaders interviewed at the EuroPCR, companies such as BIOTRONIK, Meril Lifesciences, and Reva Medical remain committed to developing a perfect scaffold and are focused on addressing issues such as strut thickness and improving the overall deliverability of the device. “
—Megha Maheshwari, Principal Analyst, Cardiovascular Insights
What’s the Buzz in the Coronary DCBs Space?
Coronary drug-coated balloons (DCBs) were the subject of numerous clinical trials investigating a wide variety of use cases and devices. For example, the BASKET-SMALL 2 trial, which assessed the usage of DCBs in small vessels—conducted among 758 patients with small de novo coronary lesions at 14 centers in Germany, Switzerland, and Austria—demonstrated favorable angiographic outcomes at 1 year.
Meanwhile, the REVELATION study, which randomized 120 patients, evaluated DCB usage in ST-segment elevation myocardial infarction (STEMI) patients and showed non-inferior results compared to conventional DES treatment at 9 months. According to investigators, the results of this study will drive increased DCB use in STEMI cases, particularly in younger patients with specific lesion types.
Finally, the pre-clinical study conducted by Concept Medical for its MagicTouch sirolimus-coated balloon (SCB)—a variant of conventional DCBs with novel coating technology—supported safety and efficacy of the device in clinical settings and its viability as a non-paclitaxel option for coronary interventions. Another long-term result for the MagicTouch SCB from a real-world NANOLUTE registry showed encouraging MACE rates up to 2 years.
“EuroPCR 2019 was host to the release of data from numerous DCB clinical trials. In the era of rapid advances in device and surgical techniques, the act of balancing device innovation, expanding indications, and improving patient outcomes has come to the forefront of the interventional space. The trials discussed above indicated that DCBs and their variants, such as SCBs, can be a valuable alternative strategy to achieving the goal of “leaving nothing behind” without compromising patient safety. In the past, the strong evidence of DES success prevented DCBs from being used outside of applications such as in-stent restenosis, small-vessel, bifurcated, and de novo lesions, where stent placement is known to be challenging. Nonetheless, positive clinical results and the expanded use of DCBs in new indications will drive further adoption of DCBs worldwide.
Additionally, the FDA's recent Breakthrough Devices Program enrolled numerous coronary DCBs—such as Concept Medical’s MagicTouch SCB, Orchestra BioMed’s Virtue sirolimus-eluting balloon (SEB), and Med Alliance’s Selution SCB—signaling the first wave of these devices poised to enter the US market on an accelerated path to approval. Given some positive results in EuroPCR, an expanding pool of clinical data, and the substantial volume of off-label usage of peripheral DCBs in coronary applications already present in the US, DCBs are anticipated to become available in the US in the near future.”
—Megha Maheshwari, Principal Analyst, Cardiovascular Insights
Renal Denervation: Clinical Trials Leading the Way
Clinical data presented at EuroPCR continued the “winning streak” for renal denervation; for example, 6-month data from the RADIANCE-SOLO trial was presented, in line with the trend of positive outcomes seen in 2-month data presented a year ago at the same conference. The discussions also included updated selection criteria for patients who can undergo renal denervation. Previously, the recommended renal denervation patient pool included hypertension patients on 3 or more than 3 medications who were not getting the desired lower blood pressure (BP) results (resistant hypertension patients); this has now changed to include hypertension patients on as few as 1 medication (moderate hypertension patients).
“Renal denervation is clearly still a hot topic of discussion. A lot has changed in the renal denervation space since the negative results from the SYMPLICITY-HTN 3 trial, which concluded that there is no correlation between BP lowering and renal denervation. The drawbacks of the study made the manufacturers reconsider the way in which trials were being conducted. The major trials on display at EuroPCR, including RADIANCE and SPYRAL, showed positive clinical data, specifically major reductions in both ambulatory and office BP with the devices compared to the sham groups. Although the results are preliminary in nature, the data is encouraging and could point toward more positive support for renal denervation devices in the future. Moreover, the expansion of the patient pool from resistant hypertension to moderate hypertension patients will further boost the target market for these devices. In light of the recent positive clinical data available and the increasing expertise of physicians in performing these procedures, I anticipate that renal denervation devices will see rapid uptake once they are launched.”
—Bishwjit Ghoshal, Analyst, Cardiovascular Insights
Ultimately, the changing interventional cardiology space is bringing new challenges and opportunities for manufacturers. DRG’s data and experts cut through the noise to provide you with actionable insights to identify growth opportunities, respond to changing market conditions, and make informed strategic decisions.
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